Trial Outcomes & Findings for Lansoprazole to Treat Children With Asthma (NCT NCT00442013)

NCT ID: NCT00442013

Last Updated: 2012-12-06

Results Overview

Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 306 participants
• Primary outcome timeframe: Measured at Weeks 0, 4, 8, 12, 24
• Results posted on: 2012-12-06

Participant Flow

Conducted from April 2007 to April 2011

Participant milestones

Measure	Lansoprazole Group 15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal	Placebo Group Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
Overall Study STARTED	157	149
Overall Study COMPLETED	131	132
Overall Study NOT COMPLETED	26	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lansoprazole to Treat Children With Asthma

Baseline characteristics by cohort

Measure	Lansoprazole Group n=157 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=149 Participants Matching placebo	Total n=306 Participants Total of all reporting groups
Age, Categorical <=18 years	157 Participants n=5 Participants	149 Participants n=7 Participants	306 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	11 years STANDARD_DEVIATION 3 • n=5 Participants	11 years STANDARD_DEVIATION 3 • n=7 Participants	11 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	63 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	86 Participants n=7 Participants	188 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	149 participants n=7 Participants	306 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Weeks 0, 4, 8, 12, 24

Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points

Outcome measures

Measure	Lansoprazole Group n=149 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=157 Participants matching placebo
Change in Juniper Asthma Control Score (ACS)	1.1 score Interval 0.9 to 1.2	1.0 score Interval 0.9 to 1.1

SECONDARY outcome

Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points

Outcome measures

Measure	Lansoprazole Group n=149 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=157 Participants matching placebo
Asthma-specific Quality of Life	5.8 score Interval 5.7 to 6.0	6.0 score Interval 5.9 to 6.2

SECONDARY outcome

Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points

Outcome measures

Measure	Lansoprazole Group n=149 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=157 Participants matching placebo
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	2.2 Liters Interval 2.1 to 2.4	2.3 Liters Interval 2.1 to 2.4

SECONDARY outcome

Timeframe: Measured daily for 24 weeks by diary

Population: The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up

Episodes of poor asthma control are defined as any one of the following:

• 2 consecutive days with peak flow at less than 70% of baseline
• prescription of oral corticosteroids for asthma
• seeking urgent medical care for asthma symptoms

EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks

Outcome measures

Measure	Lansoprazole Group n=146 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=149 Participants matching placebo
Rate of Episodes of Poor Asthma Control (EPAC)	230 number of episodes of poor asthma contrl	184 number of episodes of poor asthma contrl

SECONDARY outcome

Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points

Outcome measures

Measure	Lansoprazole Group n=149 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=157 Participants matching placebo
Asthma Symptom Utility Index (ASUI)	0.86 score Interval 0.83 to 0.88	0.88 score Interval 0.86 to 0.9

SECONDARY outcome

Timeframe: Measured at Weeks 0 and 24

Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds

Outcome measures

Measure	Lansoprazole Group n=56 Participants 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=63 Participants matching placebo
Airways Reactivity (Assessed by Methacholine PC20)	2.6 mg/mL Interval 2.0 to 3.3	2.5 mg/mL Interval 1.7 to 3.4

Adverse Events

Lansoprazole Group

Serious events: 11 serious events

Other events: 93 other events

Deaths: 0 deaths

Placebo Group

Serious events: 9 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lansoprazole Group n=147 participants at risk；n=149 participants at risk 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=150 participants at risk；n=157 participants at risk Matching placebo
Respiratory, thoracic and mediastinal disorders asthma excerbation	6.0% 9/149 • Number of events 13 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	3.4% 5/147 • Number of events 5 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Infections and infestations Vomiting and strep throat	0.00% 0/149 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	0.64% 1/157 • Number of events 1 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Psychiatric disorders Mood disorder	0.00% 0/149 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	0.64% 1/157 • Number of events 1 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Respiratory, thoracic and mediastinal disorders Pneumonia requiring hospitalization	0.00% 0/149 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	0.64% 1/157 • Number of events 1 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Gastrointestinal disorders Severe constipation	0.00% 0/149 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	100.0% 1/1 • Number of events 1 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Surgical and medical procedures Elective surgery	1.3% 2/149 • Number of events 2 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	0.00% 0/157 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,

Other adverse events

Measure	Lansoprazole Group n=147 participants at risk；n=149 participants at risk 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more	Placebo Group n=150 participants at risk；n=157 participants at risk Matching placebo
Infections and infestations upper respiratory infection	63.3% 93/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	49.3% 74/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Respiratory, thoracic and mediastinal disorders Sore throat	52.4% 77/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	39.3% 59/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Infections and infestations Group A streptococcus	4.1% 6/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	7.3% 11/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Respiratory, thoracic and mediastinal disorders Bronchitis	6.8% 10/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	2.0% 3/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Respiratory, thoracic and mediastinal disorders Pneumonia	2.7% 4/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	3.3% 5/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Ear and labyrinth disorders Otitis media	8.2% 12/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	6.7% 10/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,
Respiratory, thoracic and mediastinal disorders Acute sinusitis	10.9% 16/147 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,	11.3% 17/150 • 24 weeks Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,

Additional Information

Janet Holbrook

Johns Hopkins University

Phone: 443-287-3170

Email: ala-acrc@jhsph.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place